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Clinical Safety of the dGC Project

Clinical Safety of these clinical tools is of paramount importance to us at the RCPCH. We are a standard-setting organisation with an international reputation and as such clinical safety has been at the forefornt of our minds throughout the development of the project.

Our primary focus has been on clinical safety certification and regulatory compliance for the UK market and specifically England, because the initial work on the dGC platform has been commissioned by NHSX, which is an England-only body.

We do however recognise the need for the dGC Platform to be recognised as safe for use in other UK nations and this is our next most important priority for regulatory compliance.

Compliance for EU, US and other territories may follow, but will be subject to customer engagement in those countries or global regions. If you are an API consumer and you need the dGC platform to be certified in your region of operation, then please get in touch with us and we can discuss the requirements. Note that different growth chart references 9eg full WHO, CDC) apply in other countries, and we may need to commission further development of the API functions in order to support these.

Clinical Safety

Open Source, Transparency and Open Governance

In addition to the standard NHS clinical safety practices, a key aspect of the augmented clinical safety measures we have taken with the dGC platform is the open source codebase and completely open governance profile of the project.

Our entire codebase is open for inspection by other specialists, in a manner similar to the open peer review of academic publications which ensures high quality by enabling others to replicate our results and verify or challenge the veracity of the calculations independently. (Note that we do not rely on external validation or challenge, we have extensively internally tested the API and underlying calculations)

Digital Technology Assessment Criteria (DTAC)

  • DTAC is a UK(England)-only grouping of assessment criteria. It is relatively new, and aims to simply bring together and harmonise existing assessment criteria for digital technologies. More information is available on the NHSX website

  • DTAC incorporates the DCB0129 and DCB0160 standards for clinical safety, which the RCPCH dGC platform is compliant with.

More information on our DTAC compliance is here

DCB0129 and DCB0160 Compliance

Hazard Logs

Project Board

Clinical Safety Officer and Clinical review

Testing

Medical Device Registration

UK - MHRA and UKCA

Northern Ireland

EU - EU MDR & DoC

US FDA and other territories